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In less than a decade, nanotechnology has exploded from a relatively obscure and narrow technical field to a scientific, economic, and public phenomenon. The precipitous emergence of such a broad and significant technology has created an unprecedented opportunity to craft new regulatory or oversight approaches on a clean slate. Indeed, discussions of appropriate forms of regulatory oversight for nanotechnology have shadowed the exponential growth of the technology itself, with a rapid proliferation in calls and proposals for regulation. The actual adoption of nanotechnology regulations, however, has increasingly lagged both the technology and the academic and policy debate.

Regulatory scholars, including ourselves, have raised the option of international harmonization since the outset of the discourse on nanotechnology regulation. Despite these initial calls for harmonization, however, very little has occurred and the time for progress in this area may be quickly dwindling. Ultimately, there are appealing arguments for harmonization, summarized in part I below. To be sure, for the reasons stated in part II, formal international regulation, as traditionally understood and applied, is unlikely to be feasible anytime soon. Yet less formal "governance" approaches may still hold promise for promoting the international coordination, if not harmonization, of nanotechnology regulation; we explore these approaches in Part III.